Antiseptic Skin Cleanser
FDA Label NDC 0116-0115

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Antiseptic Skin Cleanser (NDC 0116-0115). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

skin wound and general skin cleansing

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

wheezing/difficulty breathing

  • shock
  • facial swelling
  • hives
  • rash

    • If an allergic reaction occurs, stop use and seek medical help right away

Do Not Use

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in genital area

When Using This Product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Stop Use And Ask Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control center right away

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

  • wet hands and forearms under running water
  • scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
    • wash for an additional 3 minutes with 5 mL of product and rinse under running water
    • dry thoroughly

      • Healthcare personnel handwash:

      • wet hands with water
      • dispense about 5ml of product into cupped hands and wahs in vigorous manner for about 15 seconds
      • rinse and dry thoroughly

        • Skin wound and general skin cleansing:​

        • throughly rinse the area to be cleaned with water
        • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
        • rinse again thoroughly

Other Information

  • store at 20°-25° C (68°-77° F)
  • avoid excessive heat above 40° C (104° F)

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions Of Comments?

call 1-800-587-3721 Monday through Friday 8 AM to 4:30 PM CST

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